Trial Outcomes & Findings for Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects (NCT NCT02687451)
NCT ID: NCT02687451
Last Updated: 2021-10-26
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
28 participants
Primary outcome timeframe
Up to 24 hours post dose
Results posted on
2021-10-26
Participant Flow
Participant milestones
| Measure |
Group A (6 Months - <2 Years) 0.05 mg/kg
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group A (6 Months - <2 Years) 0.10 mg/kg
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group A (6 Months - <2 Years) 0.15 mg/kg
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group B (61 Days - <6 Months) 0.10 mg/kg
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Oxymorphone HCl Multiple Dose Phase (6 Months - <2 Years)
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection.
|
Placebo
Sodium Chloride 0.9%; comparator for multiple dose phase.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
5
|
5
|
4
|
3
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
5
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group A (6 Months - <2 Years) 0.05 mg/kg
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group A (6 Months - <2 Years) 0.10 mg/kg
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group A (6 Months - <2 Years) 0.15 mg/kg
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group B (61 Days - <6 Months) 0.10 mg/kg
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Oxymorphone HCl Multiple Dose Phase (6 Months - <2 Years)
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection.
|
Placebo
Sodium Chloride 0.9%; comparator for multiple dose phase.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Single Dose Safety Population and Multiple Dose Safety Population
Baseline characteristics by cohort
| Measure |
Group A (6 Months - <2 Years) 0.05 mg/kg
n=6 Participants
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group A (6 Months - <2 Years) 0.10 mg/kg
n=5 Participants
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group A (6 Months - <2 Years) 0.15 mg/kg
n=5 Participants
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group B (61 Days - <6 Months) 0.10 mg/kg
n=5 Participants
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Oxymorphone HCl Multiple Dose Phase (6 Months - <2 Years)
n=4 Participants
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection.
|
Placebo
n=3 Participants
Sodium Chloride 0.9%; comparator for multiple dose phase.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Single Dose Safety Population
|
384.2 Days
STANDARD_DEVIATION 106.83 • n=6 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
295.2 Days
STANDARD_DEVIATION 84.19 • n=5 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
466.4 Days
STANDARD_DEVIATION 128.76 • n=5 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
108.4 Days
STANDARD_DEVIATION 11.72 • n=5 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
—
|
—
|
316.9 Days
STANDARD_DEVIATION 159.83 • n=21 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
|
Age, Continuous
Multiple Dose Safety Population
|
—
|
—
|
—
|
—
|
396.5 Days
STANDARD_DEVIATION 129.88 • n=4 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
627.0 Days
STANDARD_DEVIATION 75.11 • n=3 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
495.3 Days
STANDARD_DEVIATION 159.67 • n=7 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
|
Sex: Female, Male
Female
|
4 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
14 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
14 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
11 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
17 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
5 Participants
n=28 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
21 Participants
n=28 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=28 Participants
|
|
Weight
Single Dose Safety Population
|
9.39 Kg
STANDARD_DEVIATION 0.855 • n=6 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
9.48 Kg
STANDARD_DEVIATION 1.442 • n=5 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
10.14 Kg
STANDARD_DEVIATION 1.841 • n=5 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
5.95 Kg
STANDARD_DEVIATION 0.877 • n=5 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
—
|
—
|
8.77 Kg
STANDARD_DEVIATION 2.031 • n=21 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
|
Weight
Multiple Dose Safety Population
|
—
|
—
|
—
|
—
|
9.33 Kg
STANDARD_DEVIATION 1.797 • n=4 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
11.53 Kg
STANDARD_DEVIATION 2.079 • n=3 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
10.27 Kg
STANDARD_DEVIATION 2.109 • n=7 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
|
Height
Single Dose Safety Population
|
72.72 cm
STANDARD_DEVIATION 2.129 • n=6 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
72.28 cm
STANDARD_DEVIATION 3.943 • n=5 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
74.60 cm
STANDARD_DEVIATION 6.387 • n=5 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
59.00 cm
STANDARD_DEVIATION 3.921 • n=5 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
—
|
—
|
69.80 cm
STANDARD_DEVIATION 7.382 • n=21 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
|
Height
Multiple Dose Safety Population
|
—
|
—
|
—
|
—
|
74.25 cm
STANDARD_DEVIATION 6.551 • n=4 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
83.00 cm
STANDARD_DEVIATION 1.732 • n=3 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
78.00 cm
STANDARD_DEVIATION 6.658 • n=7 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
|
BMI
Singe Dose Safety Population
|
17.73 kg/m^2
STANDARD_DEVIATION 1.496 • n=6 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
18.04 kg/m^2
STANDARD_DEVIATION 0.904 • n=5 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
18.12 kg/m^2
STANDARD_DEVIATION 1.156 • n=5 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
17.10 kg/m^2
STANDARD_DEVIATION 1.804 • n=5 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
—
|
—
|
17.75 kg/m^2
STANDARD_DEVIATION 1.343 • n=21 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
|
BMI
Multiple Dose Safety Population
|
—
|
—
|
—
|
—
|
16.83 kg/m^2
STANDARD_DEVIATION 1.841 • n=4 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
16.73 kg/m^2
STANDARD_DEVIATION 2.775 • n=3 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
16.79 kg/m^2
STANDARD_DEVIATION 2.065 • n=7 Participants • Single Dose Safety Population and Multiple Dose Safety Population
|
PRIMARY outcome
Timeframe: Up to 24 hours post dosePopulation: Single Dose Safety Population
Outcome measures
| Measure |
Group A (6 Months - <2 Years) 0.05 mg/kg
n=4 Participants
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group A (6 Months - <2 Years) 0.10 mg/kg
n=5 Participants
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group A (6 Months - <2 Years) 0.15 mg/kg
n=1 Participants
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group B (61 Days - <6 Months) 0.10 mg/kg
n=4 Participants
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Oxymorphone HCl Multiple Dose Phase (6 Months - <2 Years)
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection.
|
Placebo
Sodium Chloride 0.9%; comparator for multiple dose phase.
|
|---|---|---|---|---|---|---|
|
Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group (Single Dose)
|
3.348 mg
Standard Deviation 3.0745
|
1.886 mg
Standard Deviation 1.5034
|
1.400 mg
Standard Deviation NA
Only one observation; therefore Standard Deviation (SD) cannot be calculated
|
0.725 mg
Standard Deviation 0.3797
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 hours post dosePopulation: Multiple Dose Safety Population
Outcome measures
| Measure |
Group A (6 Months - <2 Years) 0.05 mg/kg
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group A (6 Months - <2 Years) 0.10 mg/kg
n=1 Participants
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group A (6 Months - <2 Years) 0.15 mg/kg
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group B (61 Days - <6 Months) 0.10 mg/kg
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Oxymorphone HCl Multiple Dose Phase (6 Months - <2 Years)
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection.
|
Placebo
Sodium Chloride 0.9%; comparator for multiple dose phase.
|
|---|---|---|---|---|---|---|
|
Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group Versus Placebo Group (Multiple Dose).
|
—
|
0.80 mg
Standard Deviation NA
Only one observation; therefore Standard Deviation (SD) cannot be calculated
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Single Dose Phase: at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6 and 8 hours post dose. Multiple Dose Phase: every 0.5 hours up to 24 hours post first dose.Population: Single Dose Phase: Evaluable population =all subjects who received at least 1 dose of drug and provided at least 4 hrs of post-dose assessments and at least 3 PK assessments. Multiple dose Phase: Intent to-treat (ITT) population =all randomized subjects who received at least 1 dose of study drug and completed at least 1 post-dose pain intensity assessment. Due to safety concerns, raised by the IDMC, efficacy analyses were not conducted.
The Face, Legs, Activity, Cry, Consolability (FLACC) was used for patients between the ages of 6 months and 2 years. The FLACC scale is a validated scale that measures pain in patients who are awake or asleep based on a composite score of observations of facial expression, tonicity in legs, activity scores, the presence of crying, and whether the participant is consolable. Each category is scored on a 0 to 2 scale, which results in a total possible score of 0-10. Assessment of the behavioral score are relaxed and comfortable (0), mild discomfort (1-3), moderate pain (4-6), and severe discomfort/pain (7-10). The Neonatal Infant Pain range from 0-7 The NIPS was used for patients 0 to \< 6 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Single Dose Phase: at 0 (Baseline), 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, and 24 hours post dose. Multiple Dose Phase: Baseline before each dose onlyPopulation: The PK (Pharmacokinetic) population included all patients who received oxymorphone HCl (immediate-release oral liquid or IV formulation) and had plasma concentration data from at least 1 time point from either single-dose or multiple-dose phase to facilitate the population PK modeling and analysis. The study was terminated early due to safety concerns raised by the IDMC, only the planned safety analyses as specified in the statistical analysis plan were conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Single Dose Phase: at 0 (Baseline), 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, and 24 hours post dose. Multiple Dose Phase: Baseline before each dosePopulation: The PK population included all patients who received oxymorphone HCl (immediate-release oral liquid or IV formulation) and had plasma concentration data from at least 1 time point from either single-dose or multiple-dose phase to facilitate the population PK modeling and analysis. The study was terminated early due to safety concerns raised by the IDMC, only the planned safety analyses as specified in the statistical analysis plan were conducted.
Outcome measures
Outcome data not reported
Adverse Events
Group A (6 Months - <2 Years) 0.05 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group A (6 Months - <2 Years) 0.10 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group A (6 Months - <2 Years) 0.15 mg/kg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Group B (61 Days - <6 Months) 0.10 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Oxymorphone HCl Multiple Dose Phase (6 Months - <2 Years)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A (6 Months - <2 Years) 0.05 mg/kg
n=6 participants at risk
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group A (6 Months - <2 Years) 0.10 mg/kg
n=5 participants at risk
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group A (6 Months - <2 Years) 0.15 mg/kg
n=5 participants at risk
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group B (61 Days - <6 Months) 0.10 mg/kg
n=5 participants at risk
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Oxymorphone HCl Multiple Dose Phase (6 Months - <2 Years)
n=4 participants at risk
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection.
|
Placebo
n=3 participants at risk
Sodium Chloride 0.9%; comparator for multiple dose phase.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
Other adverse events
| Measure |
Group A (6 Months - <2 Years) 0.05 mg/kg
n=6 participants at risk
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group A (6 Months - <2 Years) 0.10 mg/kg
n=5 participants at risk
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group A (6 Months - <2 Years) 0.15 mg/kg
n=5 participants at risk
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Group B (61 Days - <6 Months) 0.10 mg/kg
n=5 participants at risk
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
|
Oxymorphone HCl Multiple Dose Phase (6 Months - <2 Years)
n=4 participants at risk
Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection.
|
Placebo
n=3 participants at risk
Sodium Chloride 0.9%; comparator for multiple dose phase.
|
|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
33.3%
2/6 • Number of events 2 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
80.0%
4/5 • Number of events 7 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 2 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
25.0%
1/4 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
33.3%
1/3 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Gastrointestinal disorders
Cardiac disorders
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
60.0%
3/5 • Number of events 3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Gastrointestinal disorders
Tachycardia
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
60.0%
3/5 • Number of events 3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
40.0%
2/5 • Number of events 2 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Injury, poisoning and procedural complications
Incision site swelling
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
40.0%
2/5 • Number of events 2 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
40.0%
2/5 • Number of events 2 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Investigations
Body temperature increased
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
40.0%
2/5 • Number of events 2 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
40.0%
2/5 • Number of events 2 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Eye disorders
Eye swelling
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Nervous system disorders
Trismus
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
1/6 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
20.0%
1/5 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/3 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/6 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/5 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/4 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
33.3%
1/3 • Number of events 1 • Time of informed consent through 14 days after the last dose
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place